se of Glycomacropeptides (GMP) in 3 – 11 year old children with classical Phenylketonuria in comparison to free amino acid (AAM) supplementation: Effect on metabolic control, micronutrient supply and wellbeing.

Not Applicable

Recruiting

• Conditions: E70.0; ORPHA:79254; Classical phenylketonuria

• Registration Number: DRKS00031977
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients with classical PKU
1.Age 3-11 years
2.Signed consent (patients and caregivers)

Exclusion Criteria

1. acute illness at start of the study, in particular infections as they might intermittingly deteriorate metabolic control
2. every chronic disease or outcome of surgery on the gastrointestinal tract, which influences resorption, metabolism or excretion of food other than PKU.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the treatment with GMP to the standard use of AAM, in 3-11 year old patients with PKU, regarding<br>1.metabolic control (Phe < 360 µmol/l)<br>2.Phe tolerance<br>3.variability of blood Phe concentrations<br>4.tyrosine blood concentrations<br>5.micronutrient serum concentrations (vitamin A, D, E, K, B12, folic acid, ferritin, zinc, selenium, calcium)

Secondary Outcome Measures

Name	Time	Method
To compare the treatment with GMP to the standard use of AAM, in 3-11 year old patients with PKU, regarding<br>1.palatability<br>2.satiation<br>3.gastro intestinal wellbeing<br>